VALIDATION PACKAGES

VALIDATION DOCUMENT SUITES.
Various enquiries have lead to us putting together validation documents to form validation suites. This simplifies the selection task. The packages have been arranged for three levels of validation for process, productio, favility and utility equipment and separate packages for computerized and HVAC equipment.
Computer Validation Package.The complete chain of regulatory required documentation for the validation of a computer / DCS / PLC / ERP, system. This Validation Package contains one of each of these documents VP - URS - DQ - VRA - IQ - OQ - PQ.
HVAC New System Qualification PackageThis package is targeted at the new build where the original design concepts are translated into a URS. From which the full flow of qualification documentation can be generated, and correctly cross referenced. Therefore we start with the VP and progress to the URS - VRA - DQ - IQ - OQ and PQ.
HVAC Validation Package.The complete suite of DQ, IQ, OQ and PQ are bundled here for the end users ease of ordering, also allowing a discount for the multi-document purchase.
Level One. You want to validate a relatively minor, new or replacement piece of equipment that is going to be used within a facility that is fully validated and subject to change control. In this case you require :- IQ, OQ, PQ.
Level Two.You want to validate a process line that has been subjected to major modification, but is validated and is continuing to use the same processes to produce the same product. In this case you require: VP, URS, IQ, OQ, PQ. Level Three.You have a new facility and you want to validate it. In this case you require:- VMP, The global master plan for the whole facility. cVMP, The master plan for all computer systems. URS, DQ, VRA, IQ, OQ, PQ. For each piece of equipment.
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